CMC Regulatory Affairs Senior Director and Group Manager

Be trusted and empowered to be the best you can be. Here we thrive in our inclusive, diverse and bold environment. We draw on our diverse knowledge to take smart risks and uncover new and creative ways to deliver better for our patients and our business.

We are now looking to recruit a Senior Director & Group Manager CMC RA Submission Excellence and Project Management managing the Oncology synthetic Portfolio .

Our Chemistry, Manufacturing, and Controls (CMC) Regulatory functions span across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines. With our expertise we interpret, anticipate and shape global Health Authority expectations to create insightful CMC and Device Regulatory Strategies. We are the bridge between our R&D functions, Operations sites, Quality and Global Supply Teams in helping safe, effective medicines reach the right patient at the right times.

What you'll do:
As a Senior Director & Group Manager you will report to the Executive Director and Section Head for Oncology within CMC RA and you are responsible for leading a number of teams of regulatory professionals delivering high quality regulatory submissions across the clinical and commercial lifecycle of the products. We are looking for you who have extensive experience across a range of business areas and will provide guidance to staff on the development of high quality CMC regulatory submissions and strategies with a focus on planning complex regulatory submissions. The role holder is expected to lead functional and cross functional improvement projects and be a member of the extended CMCRA LT.

Main Accountabilities

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To lead and be accountable for the performance of a large group consisting of several teams of regulatory professionals who will be responsible for turning regulatory CMC strategies into clear project plans with excellence in delivery . This includes recruitment and development of high quality regulatory professionals

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To ensure that the group has the capabilities and resources to deliver the portfolio across the lifecycle including CTAs, amendments, MAAs/NDAs, variations and licence renewals
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To be accountable for delivery of regulatory initiatives and improvement programmes aimed at ensuring regulatory compliance, continuous improvement, enhancing commitment to quality and improving profitability, ensuring that policy and standards meet regulatory requirements.
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To lead internal and cross functional improvement projects with a focus on harmonisation of processes and improved effectiveness across the biologics and synthetic portfolio
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To represent CMC RA with stakeholders with a focus on managing the interface with Operations.

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To ensures that the group operates to required standards of GxP appropriate to the phase of the deliverable
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Ensure that own work is performed in accordance with appropriate SHE, quality and compliance standards

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Carry out main role responsibilities, ensuring compliance with AZ Corporate Responsibility policies.

With this in mind, we think that you possess strategic leadership skills, have a deep understanding of submission excellence and is able to influence cross functional discussions with relevant senior internal and external stakeholders to deliver the overarching global regulatory strategy.

Essential Requirements:

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Degree or equivalent qualification in a scientific or technical field such as Biology, Chemistry, Pharmacy
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Extensive experience in multiple areas eg regulatory, quality assurance, drug development, manufacturing, supply chain, inclusive of the regulatory processes
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Strong proven leadership skills and experience in leading cross functional global teams.
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Ability to influence senior stakeholders both internally and externally

Desirable Requirements:

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Post graduate qualification

You will be offered a competitive salary and excellent benefits.

Why AstraZeneca?
At AstraZeneca you will be valued. Not only for your unique contribution, skills and background, but because we recognise people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energising environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there's no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It's our purpose that drives us, every day. Interested? Come and join our journey.

So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
We will go through the applications continuously so please apply as soon as possible but no later than 19 May, 2022. Welcome with your application!